FDA Notifications
June 1, 2004 2 minutes read
FDA approves Hep C drugs
On April 6, 2004, FDA approved two generic versions of the drug, ribavirin, Ribavirin Capsules, 200 mg (Sandoz, Princeton, NJ — formerly Geneva Pharmaceuticals) and Ribasphere Capsules, 200 mg, (Three Rivers Pharmaceuticals, L.L.C, Cranberry Township, PA), for the treatment of Chronic Hepatitis C.
Oral fluid-based rapid HIV test approved
The FDA on March 26, 2004, approved the use of oral fluid samples with a rapid HIV diagnostic test kit that correctly identified 99.3% of specimens from infected people (sensitivity) and 99.8% of specimens from uninfected people (specificity) in limited studies provided by the manufacturer. The test provides the result in approximately 20 minutes.
Reducing risk to health care workers
In addition to simplifying the testing process, precluding the need for a blood sample, use of the oral collection component reduces risk to health care workers performing the test by reducing exposure to blood and sharps. The original version of this rapid test — the OraQuick Rapid HIV-1 Antibody Test (OraSure Technologies Inc., Bethlehem, PA) was approved in 2002 for detection of antibody to HIV-1 in blood. The test can quickly and reliably detect antibodies to HIV-1, can be stored at room temperature, and requires no specialized equipment.
The device has an exposed absorbent pad at one end that is gently swabbed around the mouth between the teeth and the outer gums. It is then inserted into a vial containing a solution. In as little as 20 minutes, the test device will indicate whether HIV-1 antibodies are present in the solution by displaying either one bar (the control indicator, showing a negative HIV response) or two bars (the control plus reactive test indicator) in a small window on the device. Two bars indicate a presumptive positive result, requiring a Western Blot test to confirm HIV infection.
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